The following data is part of a premarket notification filed by Howmedica Osteonics with the FDA for Modification To Hoffmann Ii Micro External Fixation System.
| Device ID | K013772 |
| 510k Number | K013772 |
| Device Name: | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2001-12-03 |
| Summary: | summary |